Say No to Silicone

by
Russell Mokhiber and Robert Weissman

Dissident
Voice
November 8, 2003

Eleven
years ago, the U.S. Food and Drug Administration announced it was pulling
silicone breast implants from the market, leaving them available only to breast
cancer survivors who needed them for reconstruction or to women enrolled in
limited clinical studies.

The
reason for the action, announced then-FDA Commissioner David Kessler, was that,
under the law, "these types of products have to be shown by their
manufacturer to be safe and effective before they may be distributed and used.
Some people argue that the devices have to be proven unsafe before the FDA can
act to protect patients against their use. This is not so. The burden of proof
is an affirmative one and it rests with the manufacturer. In this instance, the
manufacturers have not shown these devices to be safe."

Although
silicone breast implants had been on the market for three decades, Kessler
said, "the list of unanswered questions is long."

"We
do not know how long these devices will last," he said.

"We
know that some of these implants will rupture, but we don't know how many of
them will rupture," he pointed out.

And,
he said, "We don't know whether there is any link between the implants and
immune-related disorders and other systemic diseases."

"Until
these basic questions are satisfactorily answered, we cannot approve these
devices."

Fast
forward to the present.

Dow
Corning, the leading manufacturer of silicone implants more than a decade ago,
is in bankruptcy.

Inamed,
a California-based company, is now seeking marketing authorization from the FDA
for silicone breast implants.

More
than a decade has passed since the FDA restricted sales of silicone implants,
but Inamed only submitted to FDA three years worth of data from a study
projected to continue for 10 years. The company sells silicone implants in
Europe and more than 60 countries worldwide, but it hasn't collected any safety
information from women in those countries that is of high enough quality to
submit to FDA.

As
a result, we still don't know the answers to many of the questions Kessler
identified, and most of what we do know is frightening.

What
we do know is that painful breast hardening which can lead to deformity, dead
tissue, loss of nipple sensation, infections and rashes are common
complications from silicone implants.

We
know that rupture rates leading silicone to spread throughout the body are
extremely high over the long term -- occurring in more than half or two thirds
of women after 10 years, according to two studies.

We
don't know whether there is any link between the implants and immune-related
disorders and other systemic diseases, though there is worrying evidence that
they do.

We
started to ask Inamed spokesperson Peter Nicholson about these matters, but
he'd only say that the data Inamed submitted to the FDA was available on the
web, and the company would not be commenting further.

Inamed's
data are indeed striking.

Even
though the company reported on only three year's test results, the numbers show
significant short-term problems. After just three years, one in five
augmentation patients and almost half of reconstruction patients required
additional surgeries.

Inamed's
data did not show particularly high rupture rates during the three-year period
of study -- in no small part because it only provided MRIs to about a third of
the women in the study, and silicone rupture can only be detected through MRIs.

Inamed's
data were replete with other flaws. For example, the company misleadingly
claimed a low incidence of lactation problems, by comparing the incidence of
problems to the overall population of women receiving augmentation, not just
those who tried to breastfeed.

These
and other problems were pointed out by advocacy groups at an FDA advisory
committee hearing convened last month to issue a recommendation on whether
Inamed's marketing application should be approved.

The
advisory committee also heard heart-wrenching testimony from more than two
dozen women with silicone implants. They described the extreme pain and
life-changing problems they have suffered as a result of silicone implants in
terms that could fail to move only those with hardened hearts. And several
highlighted an important economic component -- health insurance plans generally
do not cover surgeries to remove implants for augmentation patients, placing a
huge financial burden on sick women.

Nonetheless,
the advisory panel, a quarter of whom are plastic surgeons, and at least one of
whom was swayed by empty promises from Inamed to do ongoing follow-up research,
voted 9-6 to recommend the FDA approve Inamed's request.

The
failure for a larger majority to support the application leaves it awkward for
FDA to recommend approval.

Inamed's
chances of approval worsened last week, when Dr. Thomas Whalen, the non-voting
chair of the advisory panel, in a highly unusual move, sent a letter to FDA
commissioner Mark McClellan. Whalen called the panel decision
"misguided," emphasizing the lack of data on long-term safety. He
felt "morally compelled" to urge the FDA to deny approval, he told
reporters.

Now
the decision rests with FDA Commissioner Mark McClellan.

The
law hasn't changed since the time the FDA ordered silicone implants off the
market. The agency faces the same choice it faced in 1992, with little new
information - and much of the recent information indicating the implants'
hazards.

If
the FDA upholds its obligation under the law to approve products only that afford
"a reasonable assurance of safety," it has no choice but to deny
approval.

You
can help influence the decision. Send a message to FDA Commissioner McClellan
urging him not to approve Inamed's application. You can do this from the
website of the Command Trust Network, an information clearinghouse on implants,
at: http://www.commandtrust.org.